A South Korean medical team said Tuesday it has received approval from the U.S. Food and Drug Administration to conduct advanced clinical testing of a drug for the treatment of strokes.
The team led by Ajou University's Gwag Byoung-joo said the approval comes after successful completion of animal, pre-clinical and phase one clinical tests on Neu2000, which is is structurally based on aspirin and sulfasalazine, an anti-inflammatory agent.
Scientists said Neu2000 has great potential for treating strokes, which affect 750,000 people each year in the United States alone and kills an average of 160,000. It said prior tests showed the drug is effective in preventing the rapid deaths of brain cells following a stroke.
If a stoke occurs, patients can loose about 2 million brain cells a minute, which can lead to death in serious cases. The destruction of cells is caused by a process called excitotoxicity, meaning the damaging and killing of neurons, and excessive free radicals, or unstable atoms. If there is too much production of oxygen-based free radicals, they indiscriminately attack healthy cells instead of helping white cells kill viruses.
"Tests conducted so far showed the new material working effectively against both excitotoxicity and overactive free radicals to protect brain cells," said Gwag. He claimed the test results are better than ones for similar materials being developed by pharmaceutical companies and laboratories around the world.
The professor of medicine said in the phase one test, healthy young people and senior citizens were given doses of Neu2000 without any problems. The material was also tested by being given with 40 times the effective dosage to make certain there are no critical side effects.
In the second phase, the drug is to be given to select number of patients that suffered a stroke, while in the third phase, a test is to be conducted worldwide on 1,500-2,000 stroke victims. Once all clinical tests have been completed, local developers will request formal approval to market the drug.
"The phase-two clinical tests are critical in determining the actual effectiveness and safety of the material," the Ajou University scientist said. He added that if all subsequent clinical tests are completed without complications, a new stroke treatment drug based on Neu2000 may be available in about five years.
Ajou University, the Ministry of Science and Technology and Neurotech Pharmaceutical Co. that took part in the development of the new material, said commercial production could have a considerable impact on the stroke treatment market.
Worldwide figures are unavailable, but the U.S. market for stroke treatment drugs stands at around $43 billion annually.